Comparative Effectiveness of INTERCEPT Fibrinogen Complex (IFC) and Cryoprecipitate-AHF (Cryo-AHF) for Treatment of Trauma Associated Hemorrhage
NCT ID: NCT07218185
Last Updated: 2025-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
320 participants
OBSERVATIONAL
2026-05-31
2028-08-31
Brief Summary
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This study aims to:
* Demonstrate the feasibility and response to early administration of pre-thawed IFC compared to CRYO-AHF when ordered during resuscitation of severely injured patients with HS and functional hypofibrinogenemia.
* Assess effectiveness of early administration of pre-thawed IFC vs CRYO-AHF in severely injured patients with HS and functional hypofibrinogenemia on proximate process measures of resuscitation.
* Assess clinical outcomes in severely injured patients with HS and functional hypofibrinogenemia receiving early administration of pre-thawed IFC vs CRYO-AHF product.
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Detailed Description
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This study will assess the feasibility and effectiveness of early IFC administration in trauma patients in hemorrhagic shock with functional hypofibrinogenemia. Specifically, it aims to determine whether IFC enables faster delivery of fibrinogen replacement compared to Cryo-AHF and equivalent correction of hypofibrinogenemia. Currently, the use of IFC vs Cryo-AHF varies by center and blood bank availability, and both are considered standard-of-care treatment options. This study evaluates their performance in routine clinical use.
The primary outcomes are the proportion of patients who receive fibrinogen replacement within 60 minutes of arrival; and the correction of functional hypofibrinogenemia. Secondary outcomes include proximate measures of resuscitation including time to hemostasis, estimated blood loss, blood transfusion burden, 3-hour, 6-hour, 24-hour and 30-day mortality and adverse event incidences including: adult respiratory distress syndrome, multiple organ dysfunction, venous thromboemboli, acute kidney injury, sepsis and transfusion related acute lung injury.
Patients ≥18 years old, or \>50 Kg if age unknown, arriving within one hour of estimated time of injury with signs of hemorrhagic shock, will be screened and arrival hypofibrinogenemia determined using the point-of care Quantra® Hemostasis Analyzer. Eligible patients will receive either IFC or Cryo-AHF, depending on site assignment, in alternating 6-month treatment clusters. A post-treatment assessment of fibrinogen will be performed to assess response to fibrinogen supplementation. All data will be collected through 30 days, discharge, or death, whichever occurs first. Four Level 1 trauma centers will enroll a total of 320 patients (estimated each center to enroll approximately 80 patients) over 24 months of the study. If a site under-recruits, other sites may increase recruitment with IRB approval.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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IFC arm
Subjects will receive Pathogen Reduced Cryoprecipitated Fibrinogen Complex (IFC) for fibrinogen supplementation.
Pathogen Reduced Cryoprecipitated Fibrinogen Complex
IFC will be administered based on the study site's assigned treatment block. Study subjects will receive IFC with a point-of-care testing value of FCS \<1.6 hPa. Additional IFC may be administered per point-of-care testing or clinical judgement, as needed.
Cryo AHF arm
Subjects will receive Cryoprecipitated-Antihemophilic Factor (Cryo-AHF) for fibrinogen supplementation.
Cryoprecipitated-Antihemophilic Factor
Cryo-AHF will be administered based on the study site's assigned treatment block. Study subjects will receive Cryo-AHF with a point-of-care testing value of FCS \<1.6 hPa. Additional Cryo-AHF may be administered per point-of-care testing or clinical judgement, as needed.
Interventions
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Pathogen Reduced Cryoprecipitated Fibrinogen Complex
IFC will be administered based on the study site's assigned treatment block. Study subjects will receive IFC with a point-of-care testing value of FCS \<1.6 hPa. Additional IFC may be administered per point-of-care testing or clinical judgement, as needed.
Cryoprecipitated-Antihemophilic Factor
Cryo-AHF will be administered based on the study site's assigned treatment block. Study subjects will receive Cryo-AHF with a point-of-care testing value of FCS \<1.6 hPa. Additional Cryo-AHF may be administered per point-of-care testing or clinical judgement, as needed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years or estimated weight ≥ 50 kg, if age unknown
* Presenting to participating trauma center ≤1 hour from estimated time of injury
* Functional hypofibrinogenemia upon arrival to the trauma center as measured by POC testing (Quantra) with an FCS \< 1.6 hPa
* Hemorrhagic shock defined as:
1. Initiation of transfusion of any uncross matched blood product AND
2. Evidence of active hemorrhage as judged by the attending trauma surgeon AND
3. Initiation of the participating trauma center's MTP
* IFC or CRYO-AHF are available at the time of enrollment.
Exclusion Criteria
* Isolated drowning or hanging
* Burns \> 20% total body surface area (TBSA)
* Known pregnancy
* Admitted from a correctional facility
* Known do not resuscitate (DNR) order
* Traumatic arrest \>5 minutes
* Isolated fall from standing
* Emergency Department (ED) thoracotomy
18 Years
ALL
No
Sponsors
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Coalition for National Trauma Research
OTHER
Cerus Corporation
INDUSTRY
Responsible Party
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Locations
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University of Colorado, Anschutz Medical Center
Aurora, Colorado, United States
Jackson Memorial Hospital, University of Miami
Miami, Florida, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Barnes-Jewish Hospital, Washington University of Saint Louis
St Louis, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Rossetto A, Wohlgemut JM, Brohi K, Davenport R. Sonorheometry versus rotational thromboelastometry in trauma: a comparison of diagnostic and prognostic performance. J Thromb Haemost. 2023 Aug;21(8):2114-2125. doi: 10.1016/j.jtha.2023.04.031. Epub 2023 May 8.
Huffman G, Wilken N, Loh JH, Fazal M, Lei I, Myers A, et al. Analysis of Wastage, Savings, and Maternal and Pediatric Outcomes for Pooled Pathogen Reduced Cryoprecipitate versus Conventional Cryoprecipitate. Baylor College of Medicine; Abstract AABB Annual Meeting. 2024.
Holcomb JB, Tilley BC, Baraniuk S, Fox EE, Wade CE, Podbielski JM, del Junco DJ, Brasel KJ, Bulger EM, Callcut RA, Cohen MJ, Cotton BA, Fabian TC, Inaba K, Kerby JD, Muskat P, O'Keeffe T, Rizoli S, Robinson BR, Scalea TM, Schreiber MA, Stein DM, Weinberg JA, Callum JL, Hess JR, Matijevic N, Miller CN, Pittet JF, Hoyt DB, Pearson GD, Leroux B, van Belle G; PROPPR Study Group. Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial. JAMA. 2015 Feb 3;313(5):471-82. doi: 10.1001/jama.2015.12.
Davenport R, Curry N, Fox EE, Thomas H, Lucas J, Evans A, Shanmugaranjan S, Sharma R, Deary A, Edwards A, Green L, Wade CE, Benger JR, Cotton BA, Stanworth SJ, Brohi K; CRYOSTAT-2 Principal Investigators. Early and Empirical High-Dose Cryoprecipitate for Hemorrhage After Traumatic Injury: The CRYOSTAT-2 Randomized Clinical Trial. JAMA. 2023 Nov 21;330(19):1882-1891. doi: 10.1001/jama.2023.21019.
Curry N, Rourke C, Davenport R, Beer S, Pankhurst L, Deary A, Thomas H, Llewelyn C, Green L, Doughty H, Nordmann G, Brohi K, Stanworth S. Early cryoprecipitate for major haemorrhage in trauma: a randomised controlled feasibility trial. Br J Anaesth. 2015 Jul;115(1):76-83. doi: 10.1093/bja/aev134. Epub 2015 May 19.
McQuilten ZK, Bailey M, Cameron PA, Stanworth SJ, Venardos K, Wood EM, Cooper DJ. Fibrinogen concentration and use of fibrinogen supplementation with cryoprecipitate in patients with critical bleeding receiving massive transfusion: a bi-national cohort study. Br J Haematol. 2017 Oct;179(1):131-141. doi: 10.1111/bjh.14804. Epub 2017 Jun 27.
Holcomb JB, del Junco DJ, Fox EE, Wade CE, Cohen MJ, Schreiber MA, Alarcon LH, Bai Y, Brasel KJ, Bulger EM, Cotton BA, Matijevic N, Muskat P, Myers JG, Phelan HA, White CE, Zhang J, Rahbar MH; PROMMTT Study Group. The prospective, observational, multicenter, major trauma transfusion (PROMMTT) study: comparative effectiveness of a time-varying treatment with competing risks. JAMA Surg. 2013 Feb;148(2):127-36. doi: 10.1001/2013.jamasurg.387.
Other Identifiers
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CLI 00193
Identifier Type: -
Identifier Source: org_study_id
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